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Study to Assess the Effectiveness of RCHOP With or Without VELCADE in Previously Untreated Non-Germinal Center B-Cell-like Diffuse Large B-Cell Lymphoma Patients

Primary Purpose

Non-Germinal B-Cell-like (GCB) Diffuse Large B-cell Lymphoma (DLBCL)

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bortezomib
Rituximab
Cyclophosphamide
Doxorubicin
Vincristine
Prednisone
Sponsored by
Millennium Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Germinal B-Cell-like (GCB) Diffuse Large B-cell Lymphoma (DLBCL)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Each patient must meet all of the following inclusion criteria to be enrolled in the study:

Inclusion Criteria:

  • Patients with previously untreated DLBCL that has been sub classified as the non-GCB subtype.
  • At least 1 measurable tumor mass.
  • Availability of paraffin block with sufficient tumor tissue.
  • No evidence of central nervous system lymphoma.
  • Eastern Cooperative Oncology Group (ECOG) performance status of < or equal to 2.
  • Female patients who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or abstain from heterosexual intercourse.
  • Male patients who agree to practice effective barrier contraception or agree to abstain from heterosexual intercourse.

Patients meeting any of the following exclusion criteria are not to be enrolled in the study:

Exclusion Criteria:

  • Diagnosed or treated for a malignancy other than DLBCL within 2 years of first dose or evidence of active malignancy other than DLBCL.
  • Peripheral neuropathy of Grade 2 or greater.
  • Known history of human immunodeficiency virus (HIV) infection, unless receiving highly active antiretroviral therapy (HAART).
  • Active infection requiring systemic therapy.
  • Major surgery within 2 weeks before first dose.
  • Patients with a left ventricular ejection fraction (LVEF) or less than 45%.
  • Myocardial infarction with 6 months of enrollment or evidence of current uncontrolled cardiovascular conditions as described in the protocol.
  • History of allergic reaction/ hypersensitivity attributable to boron, mannitol, polysorbate 80 or sodium citrate dehydrate, or anaphylaxis or immunoglobulin E (IgE)-mediated hypersensitivity to murine proteins or to any component of rituximab.

Sites / Locations

  • Tower Cancer Research Foundation
  • Fountain Valley Regional Hospital
  • St. Jude Heritage Healthcare
  • Moores Cancer Center- UCSD
  • Antelope Valley Cancer Center
  • Loma Linda University Cancer Center
  • University of Southern California
  • Jonsson Comprehensive Cancer Center
  • TORI- Central Pharmacy
  • TORI- Central Regulatory
  • Oncology Care Medical Associates
  • Bay Area Cancer Research Group
  • Wilshire Oncology Medical Group
  • Sharp Healthcare
  • Central Coast Medical Oncology Corporation
  • Rocky Mountain Cancer Center
  • Florida Cancer Specialists
  • Florida Cancer Specialists & Research Institute
  • Alves/ Domenech Oncology-Hematology Clinic
  • Florida Cancer Institute ATI
  • MD Anderson Cancer Center of Orlando
  • Coastal Oncology, PL
  • Winship Cancer Institute at Emory University
  • Georgia Cancer Specialists
  • Dublin Hematology and Oncology
  • Rush University Medical Center
  • Central Indiana Cancer Centers
  • Cancer Care Center Inc. P.C.
  • Iowa Blood and Cancer Care
  • Iowa Oncology Research Association
  • Siouxland Hematology and Oncology Associates LLP
  • Kansas City Cancer Center, LLC
  • Sinai Hospital of Baltimore
  • St. Agnes Hospital of Baltimore
  • Holy Cross Hospital
  • Lahey Clinic Medical Center
  • Berkshie Hematology Oncology
  • Barbara Ann Karmanos Cancer Institute
  • Mid Michigan Physicians
  • Duluth Clinic
  • St. Luke's Hospital Cancer Care Center
  • Missouri Cancer Associates
  • Saint Luke's Cancer Institute
  • Hackensack University Medical Center
  • Hematology/Oncology Associates of Northern New Jersey, P.A.
  • Hematology Oncology Associates of South Jersey
  • St. Luke's- Roosevelt Medical Center
  • Cornell
  • Raleigh Hematology Oncology Associates P.C.
  • Summa Health System
  • Oncology Hematology Care
  • Kaiser Group Health
  • Hematology and Oncology Associates of NEPA
  • UPMC Cancer Center
  • Guthrie Clinic
  • Berks Hematology Oncology Associates
  • South Carolina Oncology Associates, PA
  • Chattanooga Oncology and Hematology Associates, PC
  • Tennessee Oncology
  • Texas Oncology Cancer Center
  • US Oncology- Central Drug
  • US Oncology- Central Laboratory
  • Oncology Consultants P.A.
  • Oncology Consultants
  • US Oncology- Central Regulatory
  • Tyler Cancer Center
  • Texoma Cancer Center
  • Virginia Cancer Institute
  • Puget Sound Cancer Centers
  • Northwest Cancer Specialists PC

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

RCHOP

Vc-RCHOP

Arm Description

RCHOP [rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.

Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.

Outcomes

Primary Outcome Measures

Progression-Free Survival (PFS) in Patients With Non-germinal Center B-cell-like (Non-GCB) Diffuse Large B-cell Lymphoma (DLBCL)
PFS is defined as the time in months from the date of randomization to the date of first documentation of progressive disease (PD) or death from any cause. The date of progression is the earliest date of a computed tomography/positron emission tomography (CT/PET) scan that shows evidence of PD. For a participant that has not progressed and is alive at the end of his/her study follow-up or at the time of start of an alternate therapy (whichever is first), PFS is censored at the last overall response assessment that is stable disease or better, and which is prior to the start of the alternate therapy, if any. Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. PD= any new lesion or increase by > 50% of previously involved sites from nadir.
Progression-Free Survival Rate
PFS is defined as the time in months from the date of randomization to the date of first documentation of progressive disease (PD) or death from any cause. The date of progression is the earliest date of a computed tomography/positron emission tomography (CT/PET) scan that shows evidence of PD. For a participant that has not progressed and is alive at the end of his/her study follow-up or at the time of start of an alternate therapy (whichever is first), PFS is censored at the last overall response assessment that is stable disease or better, and which is prior to the start of the alternate therapy, if any. Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. PD= any new lesion or increase by > 50% of previously involved sites from nadir. The progression-free survival rate is defined as the Kaplan-Meier (KM) estimate of progression-free survival at 2 years.

Secondary Outcome Measures

Overall Survival
Overall survival is defined as the time from the date of randomization to the date of death from any cause. A participant who is alive at the end of his/her study follow-up is censored at the date of last contact.
Overall Response Rate (ORR)
ORR is defined as the percentage of participants with the best overall response complete response (CR) + partial response (PR). Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. CR=disappearance of all evidence of disease and PR=regression of measurable disease and no new sites.
Complete Response Rate
Complete Response Rate is defined as the percentage of participants with the best response of Complete Response (CR). Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. CR=Disappearance of all evidence of disease.
Duration of Response
Duration of response is defined as the time (in months) from the date of first documentation of confirmed complete response (CR) or partial response (PR) to the date of first documentation of progressive disease (PD), relapse from CR or death related to disease. For a participant who has not progressed and is not known to have died due to disease under study at the end of his/her study follow-up or at the time of start of an alternate therapy (whichever is first), duration of response is censored at the last overall response assessment that is stable disease or better, and which is prior to the start of the alternate therapy, if any. Disease response was assessed using IWG-revised response criteria for malignant lymphoma. CR=Disappearance of all evidence of disease and PR=Regression of measurable disease and no new sites and PD= any new lesion or increase by > 50% of previously involved sites from nadir.
Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Negative Rate
FDG-PET negative rate is defined as the percentage of participants FDG-PET negative at the given time-point.
Time to Progression (TTP)
TTP is defined as the time from the date of randomization to the date of first documentation of progressive disease, relapse from CR, or death related to disease under study if participant did not have any documentation of disease progression prior to death caused by lymphoma or complications thereof. For a participant who has not progressed and is not known to have died due to disease under study at the end of his/her study follow-up or at the time of start of an alternate therapy (whichever is first), TTP is censored at the last overall response assessment that is stable disease or better, and which is prior to the start of the alternate therapy, if any. Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. PD= any new lesion or increase by > 50% of previously involved sites from nadir.
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) by Category
Percentage of participants in the following categories: • At least 1 TEAE • Drug-related, TEAEs • Grade 3 or higher TEAEs. Grade 3 are AEs of Severe Intensity • Grade 3 or higher drug-related, TEAEs • TEAEs resulting in study drug discontinuation • Serious TEAEs An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A Serious Adverse Event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
Percentage of Participants With Chemistry and Hematology Laboratory Values Grade 3 or Higher
Percentage of participants who shifted from a National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade 0, 1, or 2 at Baseline to a Grade 3 or higher on study (worst post-baseline grade). Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe or medically significant but not immediately life-threatening, Grade 4=Life-threatening consequences and 5=Death related to AE.

Full Information

First Posted
July 1, 2009
Last Updated
November 14, 2016
Sponsor
Millennium Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00931918
Brief Title
Study to Assess the Effectiveness of RCHOP With or Without VELCADE in Previously Untreated Non-Germinal Center B-Cell-like Diffuse Large B-Cell Lymphoma Patients
Official Title
An Open-Label, Randomized, Phase 2 Study to Assess the Effectiveness of RCHOP With or Without VELCADE in Previously Untreated Non-Germinal Center B-Cell-like Diffuse Large B-Cell Lymphoma Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Millennium Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a randomized, open-label, multi-center, phase 2 study of RCHOP with or without VELCADE in adult patients with previously untreated non-(Germinal B-Cell-like) GCB Diffuse Large B-cell Lymphoma (DLBCL). The study will determine whether the addition of VELCADE to RCHOP improves progression-free survival (PFS) in patients with non-GCB DLBCL.
Detailed Description
The drug tested in this study is called bortezomib (VELCADE®). VELCADE® was tested in people who have Non-Germinal Center B-Cell-like Diffuse Large B-Cell Lymphoma. This study looked at the efficacy of RCHOP [rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone] with or without VELCADE®. The study enrolled 206 patients. Participants were enrolled in one of the two open label treatment groups: RCHOP Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone] Participants received treatment for up to six, 21-day cycles. This multi-center trial was conducted in the United States. The overall time to participate in this study was up to 48 months. Participants made multiple visits to the clinic, and were followed for progression free survival and overall survival until patient withdrawal, death, or 2 years after the last participant was enrolled.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Germinal B-Cell-like (GCB) Diffuse Large B-cell Lymphoma (DLBCL)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
206 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RCHOP
Arm Type
Active Comparator
Arm Description
RCHOP [rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
Arm Title
Vc-RCHOP
Arm Type
Experimental
Arm Description
Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
Intervention Type
Drug
Intervention Name(s)
Bortezomib
Other Intervention Name(s)
VELCADE®
Intervention Description
Bortezomib IV
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
Rituximab IV
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
Cyclophosphamide IV
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Intervention Description
Doxorubicin IV solution
Intervention Type
Drug
Intervention Name(s)
Vincristine
Intervention Description
Vincristine IV
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
Prednisone tablet
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS) in Patients With Non-germinal Center B-cell-like (Non-GCB) Diffuse Large B-cell Lymphoma (DLBCL)
Description
PFS is defined as the time in months from the date of randomization to the date of first documentation of progressive disease (PD) or death from any cause. The date of progression is the earliest date of a computed tomography/positron emission tomography (CT/PET) scan that shows evidence of PD. For a participant that has not progressed and is alive at the end of his/her study follow-up or at the time of start of an alternate therapy (whichever is first), PFS is censored at the last overall response assessment that is stable disease or better, and which is prior to the start of the alternate therapy, if any. Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. PD= any new lesion or increase by > 50% of previously involved sites from nadir.
Time Frame
Median Follow-up of 34.3 months for RCHOP arm and 34.4 months for Vc-RCHOP arm
Title
Progression-Free Survival Rate
Description
PFS is defined as the time in months from the date of randomization to the date of first documentation of progressive disease (PD) or death from any cause. The date of progression is the earliest date of a computed tomography/positron emission tomography (CT/PET) scan that shows evidence of PD. For a participant that has not progressed and is alive at the end of his/her study follow-up or at the time of start of an alternate therapy (whichever is first), PFS is censored at the last overall response assessment that is stable disease or better, and which is prior to the start of the alternate therapy, if any. Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. PD= any new lesion or increase by > 50% of previously involved sites from nadir. The progression-free survival rate is defined as the Kaplan-Meier (KM) estimate of progression-free survival at 2 years.
Time Frame
2 Years (Median Follow-up of 34.3 months for RCHOP arm and 34.4 months for Vc-RCHOP arm)
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Overall survival is defined as the time from the date of randomization to the date of death from any cause. A participant who is alive at the end of his/her study follow-up is censored at the date of last contact.
Time Frame
Median Follow-up of 34.3 months for RCHOP arm and 34.4 months for Vc-RCHOP arm
Title
Overall Response Rate (ORR)
Description
ORR is defined as the percentage of participants with the best overall response complete response (CR) + partial response (PR). Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. CR=disappearance of all evidence of disease and PR=regression of measurable disease and no new sites.
Time Frame
End of Cycle 2, End of Treatment (Cycle 6) [Median of 16 weeks on treatment]
Title
Complete Response Rate
Description
Complete Response Rate is defined as the percentage of participants with the best response of Complete Response (CR). Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. CR=Disappearance of all evidence of disease.
Time Frame
End of Cycle 2, End of Treatment (Cycle 6) [Median of 16 weeks on treatment]
Title
Duration of Response
Description
Duration of response is defined as the time (in months) from the date of first documentation of confirmed complete response (CR) or partial response (PR) to the date of first documentation of progressive disease (PD), relapse from CR or death related to disease. For a participant who has not progressed and is not known to have died due to disease under study at the end of his/her study follow-up or at the time of start of an alternate therapy (whichever is first), duration of response is censored at the last overall response assessment that is stable disease or better, and which is prior to the start of the alternate therapy, if any. Disease response was assessed using IWG-revised response criteria for malignant lymphoma. CR=Disappearance of all evidence of disease and PR=Regression of measurable disease and no new sites and PD= any new lesion or increase by > 50% of previously involved sites from nadir.
Time Frame
Median Follow-up of 34.3 months for RCHOP arm and 34.4 months for Vc-RCHOP arm
Title
Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Negative Rate
Description
FDG-PET negative rate is defined as the percentage of participants FDG-PET negative at the given time-point.
Time Frame
End of Cycle 2 and End of Treatment (Cycle 6) [Median of 16 weeks on treatment]
Title
Time to Progression (TTP)
Description
TTP is defined as the time from the date of randomization to the date of first documentation of progressive disease, relapse from CR, or death related to disease under study if participant did not have any documentation of disease progression prior to death caused by lymphoma or complications thereof. For a participant who has not progressed and is not known to have died due to disease under study at the end of his/her study follow-up or at the time of start of an alternate therapy (whichever is first), TTP is censored at the last overall response assessment that is stable disease or better, and which is prior to the start of the alternate therapy, if any. Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. PD= any new lesion or increase by > 50% of previously involved sites from nadir.
Time Frame
Median Follow-up of 34.3 months for RCHOP arm and 34.4 months for Vc-RCHOP arm
Title
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) by Category
Description
Percentage of participants in the following categories: • At least 1 TEAE • Drug-related, TEAEs • Grade 3 or higher TEAEs. Grade 3 are AEs of Severe Intensity • Grade 3 or higher drug-related, TEAEs • TEAEs resulting in study drug discontinuation • Serious TEAEs An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A Serious Adverse Event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
Time Frame
First dose of study drug through 30 days after the last dose of study drug (Up to 26 Weeks)
Title
Percentage of Participants With Chemistry and Hematology Laboratory Values Grade 3 or Higher
Description
Percentage of participants who shifted from a National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade 0, 1, or 2 at Baseline to a Grade 3 or higher on study (worst post-baseline grade). Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe or medically significant but not immediately life-threatening, Grade 4=Life-threatening consequences and 5=Death related to AE.
Time Frame
Days 1, 4 and 10 of each cycle and end of treatment visit (Median of 16 weeks on treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Each patient must meet all of the following inclusion criteria to be enrolled in the study: Inclusion Criteria: Patients with previously untreated DLBCL that has been sub classified as the non-GCB subtype. At least 1 measurable tumor mass. Availability of paraffin block with sufficient tumor tissue. No evidence of central nervous system lymphoma. Eastern Cooperative Oncology Group (ECOG) performance status of < or equal to 2. Female patients who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or abstain from heterosexual intercourse. Male patients who agree to practice effective barrier contraception or agree to abstain from heterosexual intercourse. Patients meeting any of the following exclusion criteria are not to be enrolled in the study: Exclusion Criteria: Diagnosed or treated for a malignancy other than DLBCL within 2 years of first dose or evidence of active malignancy other than DLBCL. Peripheral neuropathy of Grade 2 or greater. Known history of human immunodeficiency virus (HIV) infection, unless receiving highly active antiretroviral therapy (HAART). Active infection requiring systemic therapy. Major surgery within 2 weeks before first dose. Patients with a left ventricular ejection fraction (LVEF) or less than 45%. Myocardial infarction with 6 months of enrollment or evidence of current uncontrolled cardiovascular conditions as described in the protocol. History of allergic reaction/ hypersensitivity attributable to boron, mannitol, polysorbate 80 or sodium citrate dehydrate, or anaphylaxis or immunoglobulin E (IgE)-mediated hypersensitivity to murine proteins or to any component of rituximab.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Millennium Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Tower Cancer Research Foundation
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Fountain Valley Regional Hospital
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
St. Jude Heritage Healthcare
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Moores Cancer Center- UCSD
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Antelope Valley Cancer Center
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Facility Name
Loma Linda University Cancer Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Jonsson Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
TORI- Central Pharmacy
City
Los Angeles
State/Province
California
Country
United States
Facility Name
TORI- Central Regulatory
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Oncology Care Medical Associates
City
Montebello
State/Province
California
ZIP/Postal Code
90640
Country
United States
Facility Name
Bay Area Cancer Research Group
City
Pleasant Hill
State/Province
California
ZIP/Postal Code
94523
Country
United States
Facility Name
Wilshire Oncology Medical Group
City
Rancho Cucamonga
State/Province
California
ZIP/Postal Code
91730
Country
United States
Facility Name
Sharp Healthcare
City
San Diego
State/Province
California
ZIP/Postal Code
32123
Country
United States
Facility Name
Central Coast Medical Oncology Corporation
City
Santa Maria
State/Province
California
ZIP/Postal Code
93454
Country
United States
Facility Name
Rocky Mountain Cancer Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Florida Cancer Specialists
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33619
Country
United States
Facility Name
Florida Cancer Specialists & Research Institute
City
Gainsville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Facility Name
Alves/ Domenech Oncology-Hematology Clinic
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33019
Country
United States
Facility Name
Florida Cancer Institute ATI
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34655
Country
United States
Facility Name
MD Anderson Cancer Center of Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Coastal Oncology, PL
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Winship Cancer Institute at Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Georgia Cancer Specialists
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30341
Country
United States
Facility Name
Dublin Hematology and Oncology
City
Dublin
State/Province
Georgia
ZIP/Postal Code
31021
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Central Indiana Cancer Centers
City
Fishers
State/Province
Indiana
ZIP/Postal Code
46227
Country
United States
Facility Name
Cancer Care Center Inc. P.C.
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
Iowa Blood and Cancer Care
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52401
Country
United States
Facility Name
Iowa Oncology Research Association
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Siouxland Hematology and Oncology Associates LLP
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51101
Country
United States
Facility Name
Kansas City Cancer Center, LLC
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Facility Name
Sinai Hospital of Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
St. Agnes Hospital of Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Facility Name
Holy Cross Hospital
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20910
Country
United States
Facility Name
Lahey Clinic Medical Center
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
Berkshie Hematology Oncology
City
Pittsfield
State/Province
Massachusetts
ZIP/Postal Code
01201
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Mid Michigan Physicians
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912
Country
United States
Facility Name
Duluth Clinic
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
St. Luke's Hospital Cancer Care Center
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Missouri Cancer Associates
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Facility Name
Saint Luke's Cancer Institute
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Hematology/Oncology Associates of Northern New Jersey, P.A.
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
Hematology Oncology Associates of South Jersey
City
Mount Holly
State/Province
New Jersey
ZIP/Postal Code
08060
Country
United States
Facility Name
St. Luke's- Roosevelt Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
Cornell
City
New York
State/Province
New York
Country
United States
Facility Name
Raleigh Hematology Oncology Associates P.C.
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Summa Health System
City
Akron
State/Province
Ohio
ZIP/Postal Code
44304
Country
United States
Facility Name
Oncology Hematology Care
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Kaiser Group Health
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Hematology and Oncology Associates of NEPA
City
Dunmore
State/Province
Pennsylvania
ZIP/Postal Code
18512
Country
United States
Facility Name
UPMC Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Guthrie Clinic
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
Facility Name
Berks Hematology Oncology Associates
City
W Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Name
South Carolina Oncology Associates, PA
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
Chattanooga Oncology and Hematology Associates, PC
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Tennessee Oncology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Texas Oncology Cancer Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
US Oncology- Central Drug
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76177
Country
United States
Facility Name
US Oncology- Central Laboratory
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76177
Country
United States
Facility Name
Oncology Consultants P.A.
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Oncology Consultants
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
US Oncology- Central Regulatory
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77380
Country
United States
Facility Name
Tyler Cancer Center
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
Texoma Cancer Center
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76310
Country
United States
Facility Name
Virginia Cancer Institute
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
Country
United States
Facility Name
Puget Sound Cancer Centers
City
Edmonds
State/Province
Washington
ZIP/Postal Code
98026
Country
United States
Facility Name
Northwest Cancer Specialists PC
City
Vancover
State/Province
Washington
ZIP/Postal Code
98686
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study to Assess the Effectiveness of RCHOP With or Without VELCADE in Previously Untreated Non-Germinal Center B-Cell-like Diffuse Large B-Cell Lymphoma Patients

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